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The FDA issued final guidance outlining what devicemakers should know about manufacturing site changes and when they should submit supplements. Read More
Working with GI Dynamics, Linhares’ focus will be on the pivotal US trial for the company’s EndoBarrier device, a treatment for type 2 diabetes and obesity. Read More
The FDA has reclassified electroconvulsive therapy (ECT) devices that treat catatonia or severe major depressive episodes or bipolar disorder as moderate risk devices with special controls. Read More